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Starting soon Not applicable

The Effect of Cold Vapor on Dyspnea, Thirst, Nausea, and Physiological Parameters in the PACU After Laparoscopic Inguinal Hernia Surgery

NCT07273162 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2025-12-20
Last updated
2026-01-16

Condition(s) studied

Patients Undergoing Laparoscopic Inguinal Hernia Repair

Investigational drug(s) / intervention(s)

Cold Vapor

Cold Vapor: Cold steam application will be performed using a Hikoneb 906 S/LCD ultrasonic nebulizer, which will generate cold steam with distilled water. Device parameters will be optimally set to steam delivery level 5 (1-10), steam density level 5 (1-10), and steam temperature 1C0 (1C0-10C0). This application will be applied to the intervention group for 15 minutes after the baseline (T0) assessment. Cold steam will not be delivered directly to the airways but will be applied to the facial area, covering the mouth and nose area. A distance of approximately 20-30 cm will be maintained between the device's steam outlet and the patient's face.

Study summary

Cold vapor application is considered a promising intervention with the potential to alleviate side effects associated with anesthesia and surgery in the postoperative period. This study aims to determine the effect of cold vapor inhalation on dyspnea, thirst, nausea, and physiological parameters following laparoscopic inguinal hernia surgery.

Hypotheses (H1);

H1a: Patients administered cold vapor will report lower dyspnea severity compared to the control group.

H1b: Patients administered cold vapor will report lower thirst levels compared to the control group.

H1c: Patients administered cold vapor will report lower nausea severity compared to the control group.

H1d: Patients administered cold vapor will show significant differences in physiological parameters compared to the control group.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Volunteering to participate in the study * Being aged 18 years or older * Being able to speak and understand Turkish * Having cognitive, affective, and communicative competence * Having intact visual and auditory functions * Having undergone elective laparoscopic inguinal hernia surgery under general anesthesia * Having an ASA score of I or II * Having a total Modified Aldrete Score of ≥9 and a consciousness score of 2 (fully awake) in the postoperative period * Not having developed vomiting prior to the intervention * Having a body temperature within the normal physiological range (36-37.5 °C) Exclusion Criteria: * Having cold vapor application planned by physician order in the PACU prior to the study * Having signs and symptoms of upper or lower airway obstruction * Developing agitation and having communication insufficiency * Having an allergy to cold vapor application * Having a diagnosis of obstructive pulmonary disease (e.g., COPD, asthma) or heart failure * Having a known history of any neurological or psychiatric disease * Having a postoperative nasogastric catheter inserted * Having received preoperative diagnoses associated with nausea, vomiting, or dyspnea

Primary outcome measure(s)

  • Survey Form — Baseline (T0)
    The form developed by the researchers consists of a total of 13 questions and collects data on the demographic (age (year), gender, body mass index (kg/m² ), ect.) and clinical characteristics (American Society of Anesthesiologists-ASA score, perioperative fasting period (min), ect.) of the patients.
  • Modified Borg Scale (MBS) for Dyspnea — Baseline (T0), 15th minute (T1) and 30th minute (T2)
    The MBS is a 12-point scale that rates dyspnea severity from 0 (no dyspnea) to 10 (intolerable dyspnea).
  • Numerical Rating Scale (NRS) for Nausea Level — Baseline (T0), 15th minute (T1) and 30th minute (T2)
    The severity of postoperative nausea in patients will be assessed using the NRS, which is scored from 0 to 10 and created by researchers. Higher scores on this scale represent higher severity of nausea.
  • Surgical Period Thirst-Related Discomfort Scale (SPTRDS) — Baseline (T0), 15th minute (T1) and 30th minute (T2)
    This six-item, three-point Likert-type scale has a single-dimensional structure. Items were rated as "did not bother" (0), "slightly bothered" (1), and "very bothered" (2). Higher scores on this scale represent higher severity of thirst.
  • Physiological Parameter Monitoring Form (PPMF) — Baseline (T0), 15th minute (T1) and 30th minute (T2)
    The monitoring form, created by the researcher as part of the study, will assess basic vital signs such as systolic (mmhg) and diastolic (mmhg) blood pressure, heart rate (pulse/min), peripheral oxygen saturation (SpO2, %) and respiratory rate (/min).

Trial sites (1)

FacilityCityRegionStatus
Erciyes University Kayseri Kayseri
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07273162 on ClinicalTrials.gov ↗ ← All trials in Turkey